Statogen Consulting

Statogen Consulting

Stephan Ogenstad

Wake Forest, NC 27587

About the Expert

Statogen Consulting, North Carolina, is multi-disciplinary team experienced in Biostatistics, Statistical Programming, Data Management, specializing in the biotechnology, pharmaceutical and medical device industries.

Areas of Expertise

  • Expertise in pharmaceutical, device, and biotech FDA and EMA submission
  • Expert biostatistician witness in high-stakes litigations
  • Medical Devices
  • Member of Data and Safety Monitoring Boards
  • Pharmacology & Pharmaceutical
  • Statistical expert in adaptive trial design, recurrent events analysis, meta-analysis, modeling and simulation

Expert's Profile

Biostatistics expert with more than 25 years of experience designing, reviewing, and analyzing hundreds of clinical trials. His experience spans from pre-clinical through Phase IV clinical trials.


Experts Keywords:
• Expert biostatistician witness in high-stakes litigations
• Expertise in pharmaceutical, device, and biotech FDA and EMA submission
• Member of Data and Safety Monitoring Boards
• Therapeutic experience: Anti-psychotics, anti-depressives, stroke and Alzheimer's disease - Breast Cancer, Cervical Cancer, Leukemia, Hodgkin's Disease, Prostate, Sarcoma, Non-small Cell Lung Cancer - Infectious Diseases (Anti-Bacterial and HIV/AIDS, CMV, HSV, HCV, COVID-19) - Local Anesthetics and Analgesics - Cardiology - Urology - Rheumatoid Arthritis - Neurology - Psoriasis
• Statistical expert in adaptive trial design, recurrent events analysis, meta-analysis, modeling and simulation

Personal Achievements

Education

  • Ph.D. in Statistics University of Stockholm, Stockholm, Sweden, 1982. Thesis title: Statistical Analysis of Censored Survival Time Data in Clinical Trials.
  • B.Sc., Mathematics, Statistics, Computing, University of Stockholm, 1974

Special Training

  • Chief Statistical Advisor to the Nobel Prize Committee for Medicine and Physiology, 1975 - 1982.
  • Senior executive positions in nonclinical and clinical biostatistics and data management with AstraZeneca, Parexel, Amgen, and Vertex Pharmaceuticals.

Organizations

  • President & Secretary - North Carolina Chapter, American Statistical Association 2007-2017 Adjunct Faculty Member and Professor of Biostatistics, Jiann-Ping Hsu College of Public Health, Georgia Southern University

Honors

  • 1999, 2000, 2001 Professional Mentor Recognition Award, School of Public Health and Health Sciences, University of Massachusetts

Military service

  • Air Force 1970-1971

Prior assignments

  • Number of cases: 6 Experience writing expert witness and rebuttal reports: 19 reports Experience testifying at deposition: 4 depositions Experience testifying at trial: 2 trials

Listed in the Following States

Statogen Consulting is listed with ExpertPages in the following jurisdictions: All US Regions and States, Canada (all Provinces).